GelRite Hand Sanitizer recalled due to facility contamination risk
DermaRite Industries is recalling GelRite Instant Hand Sanitizer due to manufacturing facility contamination. The recall affects multiple package sizes distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall due to CGMP manufacturing deviation and facility-level contamination risk where other products were found contaminated. No illnesses or injuries reported; this is a precautionary recall based on manufacturing practice violations.
Plain-English summary
DermaRite Industries, LLC is recalling GelRite Instant Hand Sanitizer, 65% alcohol, in four package sizes: 118 mL, 473 mL, 800 mL, and 1000 mL containers. The recall was issued because the product was manufactured at a facility where other products and lots were found to be contaminated, and there is evidence of Current Good Manufacturing Practice (CGMP) deviations.
The recalled product was distributed nationwide in the USA. Affected NDC codes are 61924-106-04 (118 mL), 61924-106-16 (473 mL), 61924-106-27 (800 mL), and 61924-106-34 (1000 mL). All lots with expiration dates on or before August 2027 are included in this recall, representing 115,994 containers.
Consumers who have purchased this hand sanitizer should stop using it. Contact DermaRite Industries, LLC at 7777 West Side Avenue, North Bergen, NJ 07047 for instructions on how to return or dispose of the product. Report any adverse health effects or product quality concerns to the FDA.
The recalled product
- Product
- GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug
- Hazard
- facility-contamination
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots on or before expiry date 08/2027
Distribution
Distributed nationwide across the United States.
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